Particulate cleaning, depyrogenation and sterilization are critical processes pharmaceutical packaging components undergo when utilized for injectable drugs. USP <788> “Particulate Matter in Injections”, USP <85> “Bacterial Endotoxins Test” and USP <71> “Sterility Test” are common standards established by the United States Pharmacopeia (USP) and enforced by the Food and Drug Administration (FDA) for finished injectable drugs. These standards help insure that the final product is clean, sterile and safe for the end-user.
Sterilization of componentry and packaging/container closure system, especially elastomeric or polymer materials, can dramatically affect the extractable and leachable profile of a product. In addition, chemicals used to clean packaging components can also contribute to the leachable profile of the product.
It is paramount to fully understand specific standards and the testing methods that are associated so good manufacturing practices are met at all times.
This webinar will:
- Explain key cleaning processes for finished injectable drugs
- Discuss test methods for USP <788>, USP <85>, and USP <71>
- Introduce extractables and leachables, discussing USP <1663> and <1664>
This webinar is suitable for those wishing to learn more about different processes that primary packaging components undergo when used for finished injectable drugs.